Science Is Golden
Two years after the Jack in the Box-E. coli incident, USDA unveils its sweeping inspection proposal. While industry believes it is a step in the right direction, many questions remain-as well as apprehension.
by Ken Krizner, senior editor
Over the past three decades, the battle cry in the war against food-borne illness has been consistent: The current system of visual-based inspection must be replaced with more modern, scientific methods.
Government has promised it, the meat industry has supported it and consumer groups have demanded it.
Yet, despite widespread agreement that fundamental changes were needed, the status-quo-relying on hands-on, visual inspection of beef, hog and poultry carcasses-remained intact.
Twenty-six months ago, the deaths of four children linked to E coli 0157:H7 in hamburger sold at Jack in the Box fast-food restaurants became public.
The battle cry for inspection reform became that much louder.
But again, despite widespread agreement that change was needed, only peripheral alterations were instituted by USDA. And the alterations-safe handling labels, stricter enforcement of the zero-tolerance policy and ground beef sampling-invoked more anger than support from the meat industry.
USDA promised that Jack in the Box would be a watershed event in the history of meat inspection, and that the deaths of the four children would not be in vain.
More than two years later, USDA is moving toward making that promise a reality.
Its long-awaited announcement on rules intended to introduce science into the inspection system requires anti-microbial rinses, microbial testing, temperature controls and standardized sanitation to control pathogens. The proposal appeared in the Federal Register on Feb. 1.
But the jewel in USDA's plan is the adoption of a Hazard Analysis and Critical Control Point program to prevent contamination. For years, the meat industry has been a vocal exponent of HACCP as way to combat food-borne pathogens.
The time frame for implementation of the three-part proposal is 90 days to three years (see chart, page 18).
The 276-page regulation is aimed at 6,200 federally inspected meat and poultry plants, as well as 2,900 state-inspected plants.
Comments on the proposal will be taken until June 5. USDA wants the rule to be finalized by year's end.
From all sides of the food safety debate, the introduction of HACCP is welcome news.
"[HACCP] will fundamentally reform our inspection program into a science-based system," notes USDA Acting Secretary Richard Rominger. "This system will ensure an even safer food supply."
AMI President J. Patrick Boyle notes: "We support [HACCP], and the requirement of every meat and poultry plant to have written, verifiable safe food production plans."
However, AMI expressed disappointment that the measure "falls short of long overdue comprehensive reform."
Longtime industry critic Carol Tucker Foreman points out: "While the new system isn't quite 'Star Trek,' it at long last does get beyond the horse and buggy."
USDA estimates that the industry's price tag for implementation is $733 million over a three-year period.
Afterward, the industry should pay about $231 million annually. The added cost to a pound of meat is .02 cents.
The department believes that science-based inspection will save consumers between $6 billion and $24 billion in health costs associated with food-borne illnesses over 20 years. Industry executives are skeptical of those numbers.
But there are problems on the horizon. There is a fear that implementation costs could drive some small processors out of business; the industry is critical of layering HACCP over the present system-visual carcass inspection would continue; and the Republican-led Congress wants to stop new federal regulations.
But during a news conference and subsequent interview with Meat Marketing & Technology, Michael R. Taylor, USDA acting undersecretary for food safety, was confident that the proposal would be a regulation within a year.
"Our goal is straightforward: We will reduce risk of food-borne illness associated with the consumption of meat and poultry to the maximum extent possible," he points out. "We will ensure that appropriate and feasible measures to reduce risk are taken at each step in the food production process."
Phase-in
A three-pronged proposal was designed so that near-term solutions could be implemented while processors adopt HACCP. Depending on a company's size, HACCP implementation would be between one and three years.
In the near term:
-- USDA wants plants to develop and use written standard operating procedures covering plant sanitation, and maintain a record system to document adherence to the procedures.
The proposal does not change existing sanitation requirements found in the FSIS Sanitation Handbook. Rather, the written sanitation procedures would describe specific activities deemed necessary to maintain good sanitation in a specific plant by management.
Pre-operational microbiological testing, disinfecting equipment prior to start-up, proper hand washing between carcasses during skinning and evisceration, and cleaning cattle prior to slaughter might be included in a procedure.
-- Slaughter plants will be required to use at least one antimicrobial treatment on all carcasses prior to chilling or cooling.
FSIS will approve specific antimicrobial treatments when data are available demonstrating safety and effectiveness, and do not adulterate product. Among current treatments FSIS believes will satisfy the requirements are: hot water; lactic, acetic and citric acid solution sprays; trisodium phosphate; and chlorinated water.
-- All finished carcasses and parts are to be chilled promptly after slaughter and kept cool. Plants would be required to cool the surface of meat carcasses to 50 degrees F or below within five hours and 40 degrees F or below within 24 hours from the time a carcass leaves the slaughter floor.
Processors would also have to maintain carcasses at 40 degrees F or below during handling, holding and shipping.
The temperature proposal has put a chill on processors who say they do not have the necessary equipment to store carcasses at 40 degrees F.
Taylor, however, is undeterred.
"By adopting performance standards, we can stimulate the innovative capacity of meat and poultry processors to produce safer products," he says. "Without such standards, we will lack a solid basis for judging whether a plant's HACCP plan is adequate."
The second part of the near-term solution would be microbial testing.
FSIS will establish interim targets for pathogen reduction and require daily microbial testing in slaughter plants to determine whether targets are being met.
Raw products would initially be tested for salmonella, and plants would be required to achieve targeted reductions in the incidence of salmonella within two years in relation to the current national baseline incidence rates.
Salmonella was selected as the target pathogen because it is the leading cause of food-borne illness and is present in virtually all raw food products.
Compliance would be determined by using a moving sum statistical procedure that focuses on a specified number of days within a production process.
"We believe that reducing the incidence of salmonella will directly reduce the risk of illness associated with that pathogen," Taylor points out. "We also think it will help reduce the incidence of contamination with other pathogens."
Taylor's FSIS predecessor believes the microbial testing numbers will need perspective.
"I like the idea of microbial testing," notes H. Russell Cross, former FSIS administrator and current director of the International Meat and Poultry HACCP Alliance. "We just need to be sure we do not take those numbers out of context. We cannot take just one month of numbers and pinpoint problems. We probably need to look at least a year's worth of numbers. How we use the data and statistically evaluate that data is very important."
AMI objects to the targets saying that since pathogens are naturally occurring substances, there is no guarantee of completely removing them.
The long-term solution
USDA's strategy of inspection reform is pointed toward mandatory HACCP. A HACCP system would clarify that it is industry's-not government's-responsibility to produce safe food.
A HACCP plan would be required for each type of process carried out by a plant, and it would be monitored by USDA inspectors.
Critical control points-the essence of a HACCP plan-would concentrate on areas affecting product safety rather than areas related to economic adulteration and quality.
"HACCP will require the producer to evaluate potential hazards; devise and implement controls appropriate for each product and plant to prevent or reduce the hazards; and to monitor, verify and document that the controls are working effectively," Taylor notes.
The news of HACCP-based inspection was welcomed by the industry.
"We support [HACCP] 100 percent," says Robert Langford, vice president of operations of Richardson, Texas-based Owens Country Sausage. The company has had a HACCP program for more than a year and is now reviewing the process in an effort to upgrade it.
Part of HACCP's attractiveness to USDA is that it has meat-industry support. Several hundred meat plants already use HACCP plans.
Companies will not have to alter their established plans as long as they meet the seven HACCP principals set down by the National Advisory Committee on Microbiological Criteria for Foods (see chart, page 20).
Cross, a longtime HACCP advocate, believes the time has come "to move more aggressively toward a farm-to-table HACCP approach."
The International Meat and Poultry HACCP Alliance has approved two core courses to teach HACCP-a 2.5-day introductory course that goes through model development, implementation and principles; and a half-day executive course on how to correctly spend money and time on the process.
The goal of the alliance is to have at least 15 institutions teaching the course by the end of 1995. It is also developing guidelines to certify personnel to be trainers, according to Cross.
The current focus is to train personnel in the slaughter and processing areas because that is where USDA will mandate HACCP.
Taylor suggests that processors need not wait until the final regulation is issued before adopting its principles. He also maintains that consumers need to continue practicing safe handling procedures to ensure the safety of their food.
Potential pitfalls
USDA has scaled down the aforementioned industry costs to implement and maintain the reforms to what it would cost small processors-those having $2.5 million or less in annual sales.
The department estimates that the total cost for small processors to implement HACCP over a three-year period is $157.6 million. The total estimated cost to implement the near-term initiatives is about $173 million.
There are no exemptions to the proposed regulation and Taylor does not expect that to change.
"It's feasible for companies-even small ones," he maintains.
It does not sound feasible to Steven F. Krut, executive director of the American Association of Meat Processors.
"Our biggest concern is that [small] plants will not have the dollars to implement these reforms on top of the current inspection system," he cautions.
And Krut criticized the USDA number cruncher who determined the $2.5 million line for small plants. He says the bar is too high.
"Ninety percent of our production comes from 5 percent of our industry," he adds. "The balance comes from plants far below that mystical $2.5-million level."
The numbers seem to back up Krut's claim.
Of the plants considered to be small, a recent industry survey showed that: 39 percent had less than 10 employees, 76 percent had less than 25 employees, 89 percent had less than 50 employees, and 98 percent had less than 100 employees.
Industry estimates are that 80 percent of meat and poultry processors generate less than $1 million a year in sales.
"The amount of goods sold does not reflect the dollars left to implement new programs that do not contribute to improved production," Krut maintains.
He also criticized USDA for laying the reforms on top of the present system of visually inspecting each carcass.
"It is heartbreaking that [USDA] is not even looking to dismantle the present system," he notes.
AMI's Boyle adds: "The system needs a total overhaul. To do this will require both regulatory and legislative changes."
FSIS Associate Administrator Thomas J. Billy points out that it would take an act of Congress to change the current inspection system.
"We could not stop visually inspecting each product even if we wanted to," he says. "Right now, it's the law."
Taylor adds that steeper penalties for non-compliance, sought by consumer groups, must come from Congress.
Climbing the (Capitol) Hill
Congressional action, or lack thereof, could be the random element.
Sen. Bill Bradley (D-N.J.) plans to introduce legislation that would boost penalties, give USDA authority to fine violating plants, shut down repeat offenders, and remove contaminated meat from stores.
Industry is also expected to lobby for legislation in Congress that would get rid of carcass inspection by government employees and replace it with inspection by plant employees. This would meet heavy resistance from consumer groups.
But Republicans are in charge now.
"[USDA] proposed huge new rules and did not undo a single requirement in return," says a spokesman for a GOP congressman. "That is not smart."
A House subcommittee chaired by Rep. Thomas Bliley (R-Va.) has recently voted to put a moratorium on new federal regulations, including USDA's inspection proposal. Under the measure, any rule dealing with human health, safety or the environment would have to pass a risk-benefit analysis.
Though the bill must pass both chambers of Congress and a White House spokeswoman tells MM&T that President Clinton would veto such a bill, it does indicate the anti-regulatory fervor that grips Washington.
The battle has been joined
An old Chinese proverb states: "A journey of a thousand miles must begin with a single step."
USDA has taken the first step on the journey to transform meat inspection from visual-based to science-based.
But it has been a slow step. In 1994, at least 99 cases of food-borne illness relating to meat were reported to the Centers for Disease Control and Prevention.
"We are talking about fundamental change to a 90-year-old-system," Taylor says. "Sometimes change comes slowly."
Nancy Donley, whose son Alex was one of the four who died from eating contaminated hamburger meat from Jack in the Box, says: "We desperately need reform; we need to pass legislation now that will protect other children."
The question is: Will outside influences put a stop to the proposal, or is the beginning of science-based inspection at hand?
If USDA cannot deliver science-based inspection, then reform could be set back at least a decade, which in turn would damage the industry's reputation.
USDA officials are confident that it is the beginning. Industry and consumer advocates are more cautious, but also more optimistic than ever.
If so, then the inspection battle cry will be reinforced with some new battle gear.
Here are the answers to some of the questions being asked by the meat industry in the wake of USDA's proposed inspection reform regulation.
MM&T: Is their a small-company exemption to the HACCP regulation, similar to the nutrition labeling regulation?
Michael Taylor, USDA acting undersecretary for food safety: No. All FSIS-inspected meat and poultry plants will be required to meet the requirements once the final regulation is issued.
MM&T: Will a plant be required to have just one HACCP plan or a plan for each process?
Taylor: A HACCP plan will be required for each type of processing activity carried out by the plant.
MM&T: Will meat company employees who deal with HACCP have to be certified by USDA?
Thomas Billy, FSIS associate administrator: [USDA] does not plan on certification. Instead, the proposal spells out what should be covered during a three-day course in essential HACCP training. We are leaving the training and certification to the meat industry. However, if the industry wants to have its employees certified, that could be arranged.
MM&T: Several companies already operate HACCP plans. If these plans do not exactly match the final rule, will they have to be brought into compliance?
Billy: All plans must meet the seven basic principles of HACCP [established by the National Advisory Committee on Microbiological Criteria for Foods]. But it is hard to believe that a company would have a HACCP plan that did not fully address these fundamental principles. The more likely scenario is that companies go beyond our proposed minimum requirements, which is fine.
MM&T: How often will plants have to conduct microbial testing and what will the testing entail?
Taylor: A single sample per species, per plant, per day will verify process control. It won't determine what the microbial levels are of a particular lot on a particular day, but it will verify whether target levels of pathogens are being achieved during a specific period of time.
We initially propose interim targets for reducing the incidence of salmonella in meat and poultry carcasses, and ground meat and poultry products-coupled with requirements for all affected plants to conduct microbial testing to determine whether targets are being achieved.
Progress can be made in pathogen reduction by taking advantage of current technologies and industry capabilities, even as HACCP develops, and the scientific basis for setting more definitive targets, guidelines and standards evolve.
FSIS wants each plant, at a minimum, to bring the incidence of salmonella contamination below current national baseline criteria for specific products within two years of the proposal's effective date.
MM&T: Who will pay for the microbial testing?
Billy: The day-to-day microbial testing will be at the expense of [individual] companies.
MM&T: Will there be a reduced number of inspectors in plants?
Taylor: This proposal is not about reducing the number of inspectors; it is about filling a critical gap in the current inspection system. We need to develop the role of inspectors in a HACCP environment.
MM&T: Does this regulation improve the method for tracing contaminated meat back to its source?
Billy: When HACCP is implemented, a number of hazards associated with animals arriving at the slaughter plant will be addressed through control measures carried out by producers. The records associated with those critical controls will be documented and linked to the production lot. This will give us a better opportunity to trace-back animals if necessary.
Over the longer term, the proposal seeks to work with producers to identify methods to reduce hazards that might be associated with various animals. There is no reason why we shouldn't encourage producers to have better information and records.
MM&T: FSIS recently eliminated prior approval for using antimicrobial rinses and hot water rinses on carcasses. Will the agency eliminate prior approvals for other methods to combat contamination?
Taylor: With the shift to HACCP, some prior approvals could be eliminated or modified.
We believe that some procedures stifle new technology, and we need to encourage industry to develop technologies that will make products safer. We will publish an advanced notice of proposed rule-making this spring in which we state our objectives.
What USDA is Proposing
USDA's proposed regulation to introduce scientific testing into the meat and poultry inspection system is broken down into three phases:
New plant safeguards-90 days after the final rule is issued, meat and poultry plants will operate under a sanitation plan designed to protect products from bacteria. Plants will observe safe processing temperatures and use bacteria-fighting rinses.
Ë Microbial testing-Within two years after the final rule is issued, meat and poultry plants would have to reduce bacteria to USDA-set target levels. Testing would begin 90 days after the final rule and tracking would begin six months later.
Ì Mandatory HACCP-One to three years after the final rule is issued, meat and poultry plants would be protected by a HACCP program based on identifying critical control points. A HACCP plan would spell out what plant employees must do to protect product. Federal inspectors would verify how well the plan is working and hold the plant responsible for its success.
USDA is also working with other federal and state agencies, including FDA, to improve farm-to-table safeguards in meat and poultry production.
E. Coli Outbreaks Linked to Meat in 1994
Washington: Two people die from E. coli 0157:H7 infections linked to retail store-bought ground beef.
Oregon: Ten cases of E. coli 0157:H7 are linked to retail ground beef.
Minnesota: Six cases of E. coli 0157:H7 are linked to retail ground beef.
California: Three adults contract E. coli 0157:H7, and one dies in San Diego.
Ohio: A 53-year-old woman dies after contracting E. coli 157:H7.
Nebraska: Twenty-three cases of E. coli 0157:H7 are linked to grocery store ground beef.
North Dakota: Fifteen cases of E. coli 0157:H7 are linked to restaurant ground beef.
The Seven HACCP
Principles
Here are the seven HACCP principles set down by the National Advisory Committee on Microbiological Criteria for Foods:
1. Conduct a hazard analysis.
2. Identify critical control points in the process.
3. Establish critical limits for preventive measures associated with each critical control point.
4. Establish critical control point monitoring requirements.
5. Establish corrective action.
6. Establish effective record-keeping procedures.
7. Establish procedures for verifying that the HACCP system is working correctly.
100
of
Inspection
1890s
-- Congress gives USDA the responsibility for ensuring that beef exports bound for Europe meet safety requirements. USDA is also authorized to conduct antemortem and post-mortem livestock inspection for beef intended for distribution in the United States.
1900s
-- Upton Sinclair's novel, "The Jungle," dramatizes unsanitary conditions in meat packing plants. Congress passes the Meat Inspection Act in 1906, establishing sanitary standards, antemortem inspection of animals and post-mortem inspection of carcasses.
1950s
-- The post-World War II years impact heavily on the meat industry, as well as the burgeoning poultry industry. New establishments open, including McDonald's and other fast-food restaurants. Meat and poultry companies begin developing new processed products. The market for ready-to-cook poultry quadruples between 1946 and 1976.
-- Congress passes the Poultry Products Inspection Act in 1957, mandating daily inspection of poultry.
1960s
-- New technologies, new ingredients and specialization add complexity to inspection. The growth of processing calls for disciplines in food technology and microbiology. FSIS begins recruiting personnel with skills necessary to design processing inspection systems.
-- Rachel Carson's "Silent Spring" raises public awareness of the possible harmful affects of pesticides and other chemical contaminants in food. As a result, USDA establishes the National Residue Program [1967] to determine and control the presence and level of those chemicals in meat and poultry that may present a public health risk.
-- NASA contracts with Pillsbury to produce a "zero defects" system to guarantee safety in the foods astronauts would consume in space. Pillsbury identifies the hazards inherent in the product and process, and devises preventive measures that could be controlled and monitored. The program is called Hazard Analysis and Critical Control Point.
-- The Wholesome Meat Act [1967] and Wholesome Poultry Products Act [1968] bring uniformity to the regulation of products shipped in interstate, intrastate and foreign commerce. The acts also give USDA authority over meat-allied industries.
1970s
-- The need to focus on food-borne pathogens moves to the forefront.
-- A USDA-commissioned report observes that high-speed production lines severely stresses inspectors who are "forced to work at speeds well over those at which peak effectiveness is expected."
-- Scientific evidence indicates that with improvements in animal health, little of the carcass examination performed by inspectors is necessary. But carcass-by-carcass inspection continues.
1980s
-- The National Academy of Sciences recommends HACCP as a way to improve inspection. Consequently, the National Advisory Committee on Microbiological Criteria for Foods establishes seven basic principles for HACCP.
-- Congress grants FSIS the authority to vary the frequency and intensity of inspection in processing plants based on the risk presented by a particular plant and process. But consumer groups and some FSIS employees oppose it. Industry, too, is skeptical. FSIS withdraws the plan.
-- FSIS initiates the Streamlined Inspection Service in five beef plants [1988]. SIS puts more responsibility for quality control on processors' shoulders and reduces government oversight. SIS elicits severe criticism from consumer groups and inspectors who fear the test is a pretext to deregulation. Results are mixed. Congress ends SIS funding in April 1993.
1990s
-- Four children die and more than 500 become ill on the West Coast in early 1993 as a result of contaminated hamburger meat traced to Jack in the Box fast-food restaurants.
-- Two years later, USDA announces its proposal to reform meat inspection, based on HACCP and microbial testing. But traditional visual inspection will continue.